- PO (Adults): Concurrent potent CYP3A inhibitors (with or without potent CYP3A inducers) including protease inhibitors (except tipranavir/ritonavir), elvitegravir/ritonavir, ketoconazole, itraconazole, clarithromycin, and other potent CYP3A inhibitors — 150 mg twice daily; Concurrent potent CYP3A inducers (without a potent CYP3A inhibitor) including efavirenz, rifampin, etravirine, carbamazepine, phenytoin, and phenobarbital — 600 mg twice daily; Noninteracting concomitant medications including NRTIs, tipranavir/ritonavir, nevirapine, raltegravir, enfuvirtide, and other medications that not potent CYP3A inhibitors/inducers — 300 mg twice daily.
- PO (Children
40 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir), — 150 mg twice daily (as tablets [if 2 yr] or oral solution); Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 300 mg twice daily (as tablets [if 2 yr] or oral solution). - PO (Children 30–<40 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — 100 mg twice daily (as tablets [if 2 yr] or oral solution); Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 300 mg twice daily (as tablets [if 2 yr] or oral solution).
- PO (Children 20–<30 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — 75 mg twice daily (as tablets [if 2 yr] or oral solution); Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 200 mg twice daily (as tablets [if 2 yr] or oral solution).
- PO (Children 14–<20 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — 50 mg twice daily (as tablets [if 2 yr] or oral solution); Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 200 mg twice daily (as tablets [if 2 yr] or oral solution).
- PO (Children 10–<14 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — 50 mg twice daily (as tablets [if 2 yr] or oral solution); Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 150 mg twice daily (as tablets [if 2 yr] or oral solution).
- PO (Children 6–<10 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — Not recommended; Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 100 mg twice daily (as oral solution).
- PO (Children 4–<6 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — Not recommended; Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 40 mg twice daily (as oral solution).
- PO (Children 2–<4 kg): Concurrent potent CYP3A inhibitors (with or without a CYP3A inducer), including clarithromycin, cobicistat, elvitegravir/ritonavir, itraconazole, ketoconazole, nefazodone, and protease inhibitors (except tipranavir/ritonavir) — Not recommended; Concurrent potent and moderate CYP3A inducers (without a potent CYP3A inhibitor), including carbamazepine, efavirenz, etravirine, phenobarbital, phenytoin, and rifampin — Not recommended; Noninteracting concomitant medications that are not potent CYP3A inhibitors/inducers, including dolutegravir, enfuvirtide, nevirapine, all NRTIs, raltegravir, and tipranavir/ritonavir — 30 mg twice daily (as oral solution).
Renal Impairment
- (Adults): CCr <30 mL/min or on hemodialysis (not receiving potent CYP3A inhibitors or potent or moderate CYP3A inducers) — 300 mg twice daily; ↓ dose to 150 mg twice daily if symptoms of orthostatic hypotension occur; CCr <30 mL/min or on hemodialysis (receiving potent CYP3A inhibitors or potent or moderate CYP3A inducers) — Contraindicated.
Renal Impairment
- (Children 2 kg): CCr <30 mL/min or on hemodialysis (receiving potent CYP3A inhibitors or potent or moderate CYP3A inducers) — Contraindicated.